Albuterol

INDICATIONS & USAGE Albuterol tablets are indicated for the relief of bronchospasm in adults and children 6 years of age and older with reversible obstructive airway disease.

DOSAGE & ADMINISTRATION The following dosages of albuterol tablets are expressed in terms of albuterol base. Usual Dosage Adults and Children Over 12 Years of Age The usual starting dosage for adults and children 12 years and older is 2 or 4 mg three or four times a day. Children 6 to 12 Years of Age: The usual starting dosage for children 6 to 12 years age is 2 mg three or four times a day. Dosage Adjustment Adults and Children Over 12 Years of Age For adults and children 12 years and older, a dosage above 4 mg four times a day should be used only when the patient fails to respond. If a favorable response does not occur with the 4 mg initial dosage, it should be cautiously increased stepwise up to a maximum of 8 mg four times a day as tolerated. Children 6 to 12 Years of Age Who Fail to Respond to the Initial Starting Dosage of 2 mg Four Times a Day For children from 6 to 12 years of age who fail to respond to the initial starting dosage of 2 mg four times a day, the dosage may be cautiously increased stepwise, but not to exceed 24 mg/day (given in divided doses). Elderly Patients and Those Sensitive to Beta-adrenergic Stimulators An initial dosage of 2 mg three or four times a day is recommended for elderly patients and for those with a history of unusual sensitivity to beta-adrenergic stimulators. If adequate bronchodilation is not obtained, dosage may be increased gradually to as much as 8 mg three or four times a day. The total daily dose should not exceed 32 mg in adults and children over 12 years and older.

WARNINGS Paradoxical Bronchospasm Albuterol tablets can produce paradoxical bronchospasm, which may be life threatening. If paradoxical bronchospasm occurs, albuterol tablets should be discontinued immediately and alternative therapy instituted. Cardiovascular Effects Albuterol tablets, like all other beta-adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon after administration of albuterol tablets at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta-agonists have been reported to produce electrocardiogram (ECG) changes, such as flattening of the T wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, albuterol tablets, like all sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension. Deterioration of Asthma Asthma may deteriorate acutely over a period of hours, or chronically over several days or longer. If the patient needs more doses of albuterol tablets than usual, this may be a marker of destabilization of asthma and requires reevaluation of the patient and the treatment regimen, giving special consideration to the possible need for anti-inflammatory treatment, e.g., corticosteroids. Use of Anti-Inflammatory Agents The use of beta-adrenergic agonist bronchodilators alone may not be adequate to control asthma in many patients. Early consideration should be given to adding anti-inflammatory agents, e.g., corticosteroids. Immediate Hypersensitivity Reactions Immediate hypersensitivity reactions may occur after administration of albuterol tablets, as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema. Albuterol tablets, like other beta-adrenergic agonists, can produce a significant cardiovascular effect in some patients, as measured by pulse rate, blood pressure, symptoms, and/or electrocardiographic changes. Rarely, erythema multiforme and Stevens-Johnson syndrome have been associated with the administration of oral albuterol sulfate in children.

CONTRAINDICATIONS Albuterol tablets are contraindicated in patients with a history of hypersensitivity to albuterol, or any of its components.

ADVERSE REACTIONS In clinical trials, the most frequent adverse reactions to albuterol tablets were: Percent Incidence of Adverse Reactions Reaction Incidence Percent Central nervous system Nervousness 20% Tremor 20% Headache 7% Sleeplessness 2% Weakness 2% Dizziness 2% Drowsiness <1% Restlessness <1% Irritability <1% Cardiovascular Tachycardia 5% Palpitations 5% Chest discomfort <1% Flushing <1% Musculoskeletal Muscle cramps 3% Gastrointestinal Nausea 2% Genitourinary Difficulty in micturition <1% Rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema have been reported after the use of albuterol tablets. In addition, albuterol tablets, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vomiting, vertigo, central nervous system stimulation, unusual taste, and drying or irritation of the oropharynx. The reactions are generally transient in nature, and it is usually not necessary to discontinue treatment with albuterol tablets. In selected cases, however, dosage may be reduced temporarily; after the reaction has subsided, dosage should be increased in small increments to the optimal dosage. To report SUSPECTED ADVERSE REACTIONS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.